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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problems Bent; Positioning Failure
Event Type  Malfunction  
Manufacturer Narrative

If explanted, give date: not applicable, cartridge is not an implantable device. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that the intraocular lens (iol) was stuck inside a 1mtec30 cartridge and the cartridge tip was bent when they opened the carton. No additional information was provided.

 
Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on 08/22/2017. Device returned to manufacturer?: yes. Device evaluation: the cartridge was returned to the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed scarce amounts of residue of what appears to be viscoelastic at the beginning of the cartridge tube. Viscoelastic residue was not observed in the loading zone of the cartridge. The cartridge tube was observed with a bump in where the lens is stuck. The complaint was verified however the complaint could be related to the scarce amount of viscoelastic used. Manufacturing records review: the manufacturing records for the cartridge were reviewed. The product was manufactured and released according to specification. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified. All pertinent information available to abbott medical optics has been submitted.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA 92705
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key6832508
Report Number2648035-2017-01575
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date05/19/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC05983
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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